FDA product code QCH: Assayed Quality Control Material For Clinical Microbiology Assays
QCH is the FDA product code for assayed quality control material for clinical microbiology assays. It is a Class II device, regulated under 21 CFR 866.3920 and reviewed by the Microbiology panel. FDA has cleared 1 510(k) submission under QCH, 1 in the last five years. The average 510(k) review took 496 days (median 496); 496 days on average over the last three years.
Definition
Serologic controls for microbiology assays
Classification
| Field | Value |
|---|---|
| Device name | Assayed Quality Control Material For Clinical Microbiology Assays |
| Device class | Class II |
| Regulation | 21 CFR 866.3920 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for QCH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2025 | 1 | 496 |
Compare with all 510(k) review times · Search every QCH clearance
Top QCH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Techno-Path Manufacturing , Ltd. | 1 | 2025-12-30 |
Most recent QCH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242492 | Techno-Path Manufacturing , Ltd. | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG); Multichem ID-GNeg (09339906190); Multichem ID-GNeg (SR102N); Multichem ID-GNeg (SR102MN) | 2025-12-30 | 496 |
Recalls for QCH devices
openFDA lists no recalls for product code QCH.
Frequently asked questions
What is FDA product code QCH?
QCH is the FDA product code for assayed quality control material for clinical microbiology assays. It is a Class II device, regulated under 21 CFR 866.3920 and reviewed by the Microbiology panel.
What device class is QCH?
Class II, regulation 21 CFR 866.3920. Typical premarket route: 510(k).
How long does a 510(k) take for product code QCH?
Across 1 cleared submissions the average was 496 days from receipt to decision (median 496).
Which companies have the most QCH clearances?
Techno-Path Manufacturing , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code QCH
- Run a recall and safety report across every QCH manufacturer
- Watch product code QCH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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